Oncology Regulatory Affairs Lead – COFEPRIS Expert

Merck Gruppe - MSD Sharp & Dohme; Ciudad de México; Hybrid; MXN 900,000 - 1,300,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Mexico City seeks an experienced Regulatory Affairs Manager (Senior Specialist) to lead regulatory submissions, lifecycle management, and compliance for oncology products. You will coordinate with COFEPRIS and cross-functional teams to secure timely MA approvals and maintain product registrations.

The role demands extensive knowledge of local regulations, strong English skills, and the ability to drive regulatory strategies in a dynamic environment.

Qualifications

• Degree in Pharmacy, Life Sciences, or a related field, or equivalent qualification.
• Minimum of 8 years of experience in a Registration Department or equivalent role, including interactions with COFEPRIS.
• Strong knowledge of local legislation, procedures, and guidelines governing pharmaceutical products.
• Excellent verbal and written communication skills.
• Strong organizational and planning abilities.
• Experience in Oncology is required, Biological, Biotechnological, small molecules, etc.
• High attention to detail, adaptability, and the ability to manage multiple priorities under tight deadlines.
• Disciplined, proactive, and able to coordinate tasks effectively across teams.
• Ability to navigate complex regulatory environments with diplomacy and assertiveness when engaging with internal and external stakeholders.
• Proficiency in English.
• Client-oriented mindset aligned with our company´s leadership vision.
• Focus on results, strategic planning, accountability, and execution excellence.

Responsibilities

• Submit new Marketing Authorization applications in a timely and high-quality manner.
• Lead regulatory authority queries related to product registrations and major indications.
• Negotiate to achieve optimal regulatory outcomes with authorities.
• Develop local action plans to support authorization, launch, and lifecycle integration.
• Maintain compliance through variations, renewals, and related activities within timelines.
• Communicate approval updates to stakeholders and align with process changes.
• Design local action plans for major indications in line with MA processes.
• Manage CMC post-approval changes, variations, renewals, labeling and lifecycle regulatory tasks.
• Provide regulatory status updates to internal teams.
• Support SOP development to ensure regulatory compliance.
• Assist with regulatory documentation updates per agency requirements.
• Collaborate with local teams on Quality Notifications, GMP inspections, and ARRs.

Skills

Regulatory Strategy Development

Regulatory Submissions

Project Management

Pharmacovigilance

Global Communications

Detail-Oriented

Process Improvements

Drug Regulatory Affairs

Audits Compliance

English Proficiency

Education

Degree in Pharmacy, Life Sciences, or related field

Job description

Merck Gruppe - MSD Sharp & Dohme in Mexico City seeks an experienced Regulatory Affairs Manager (Senior Specialist) to lead regulatory submissions, lifecycle management, and compliance for oncology products. You will coordinate with COFEPRIS and cross-functional teams to secure timely MA approvals and maintain product registrations.

The role demands extensive knowledge of local regulations, strong English skills, and the ability to drive regulatory strategies in a dynamic environment.